Vice President - Quality Assurance, GMP

SUMMARY/JOB PURPOSE

The Vice President, Quality Assurance - GMP is accountable for leading the enterprise GMP Quality Assurance strategy and ensuring GMP QA activities are aligned with the enterprise Quality system across clinical and commercial operations.

This role serves as the final decision authority for product disposition while ensuring compliance with global regulatory requirements.

As a member of the PSC leadership team, the Vice President, Quality Assurance - GMP partners with clinical and commercial manufacturing, supply chain, logistics, third-party contractors, GCP QA and Quality Systems to ensure GMP requirements are supported, governed and escalated effectively.

ESSENTIAL DUTIES/RESPONSIBILITIES

• Lead and oversee the GMP Quality Assurance department

• Drive compliant execution across all GMP QA responsibilities in alignment with the enterprise GMP Quality Assurance strategy

• Lead organizational readiness for GMP inspections at Exelixis and third-party vendors, including regulatory inspections by the FDA and other agencies and audits or inspections by collaboration partners

• Lead Quality input into GMP quality agreements to ensure they support operational needs, compliance expectations and appropriate Quality oversight

• Oversee final review and disposition of clinical and commercial materials and products in compliance with global regulatory standards to ensure reliability, quality, efficacy and compliance

• Lead GMP Operations QA, Labeling QA, Audit and Inspection Readiness and associated Quality functions to ensure QA GMP operates at the highest standards

• Partner with the Head of Quality Systems to ensure GMP QA requirements are reflected in Quality systems, governance processes, and continuous improvement activities

• Oversee labeling governance for clinical and commercial products to support regulatory compliance and consistency

• Partner with PSC functions to establish effective GMP supplier quality and vendor audit programs

• Ensure independent Quality oversight of manufacturing, testing, distribution and external partners

• Ensure effective execution of investigations, root cause analysis, risk assessments, change controls and CAPAs at Exelixis and third-party contractors

• Ensure performance metrics for GMP QA are established, appropriate and regularly assessed

• Identify, evaluate and escalate product quality risks to senior leadership

• Represent GMP Quality in cross-functional governance forums and regulatory interactions

• Lead and develop organizational capability, including talent strategy and succession planning

• Performs other duties as assigned

• Complies with all policies and standards

SUPERVISORY RESPONSIBILITIES

• Provide executive leadership for GMP Quality Assurance, including GMP Operations QA, audit, inspection readiness and associated Quality functions

• Develop organizational structure, recruit talent and manage performance of direct and indirect reports

• Set organizational priorities and align resources to meet business objectives

• Partner across functions to achieve organizational goals and ensure compliance

• Serve on the enterprise Quality leadership team. providing independent oversight, cross-functional governance, and escalation of Quality-related risks and decisions in partnership with GCP/GVP QA and Quality Systems and Process functions

EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
Education

• BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience; or,

• MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience; or,

• PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience; or,

• Equivalent combination of education and experience

• Advanced degree preferred

Experience

• Extensive experience in biotechnology, pharmaceutical or regulated industry

• Significant leadership experience in GMP Quality Assurance

• Experience with regulatory inspections and global GMP audit programs

• Experience overseeing external manufacturing and supply networks

• Experience leading Quality organizations through commercialization, expansion or organizational change preferred

Knowledge, Skills and Abilities
Required:

• Comprehensive knowledge of global GMP regulations and Quality systems

• Advanced leadership, analytical and problem-solving skills

• Strong executive communication skills with the ability to translate technical concepts for diverse audiences

• Ability to work with ambiguity and make risk-based decisions

• Ability to align Quality strategies across functions and GxP domains

• Demonstrated ability to lead organizational transformation and change

• Experience interacting with global regulatory agencies and executive governance bodies

• Ability to influence enterprise strategy and organizational decision-making

#LI-HG1

Location: Alameda, CA

Range for this position: $290,000 - $366,500

The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

Exelixis is an Equal Opportunity Employer. We are committed to fostering an inclusive environment where everyone can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy (including lactation, childbirth, or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, citizenship or immigration status, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other characteristic protected by applicable federal, state, or local law. We are also committed to providing reasonable accommodations to qualified individuals with disabilities, unless undue hardship and/or a direct threat to the health and/or safety of the individual or others would result.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [email protected].

Exelixis is an E-Verify employer.

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

DISCLAIMER: 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.